Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2016-05-27
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2016189EN.01000901.xml










27.5.2016   


EN


Official Journal of the European Union


C 189/9





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2016/C 189/02)
—   Issuing, maintenance or modification of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




4.4.2016


Baytril — Rectificative Decision — Article 34


Enrofloxacin


See Annex I


See Annex I


5.4.2016




4.4.2016


Baytril — Rectificative Decision — Article 35


Enrofloxacin


See Annex II


See Annex II


5.4.2016




28.4.2016


Cymevene intravenous — Art. 30


ganciclovir


See Annex III


See Annex III


2.5.2016




4.4.2016


Tobramycin VVB — Community Referrals — Article 29


tobramycin


See Annex IV


See Annex IV


5.4.2016




4.4.2016


Gutal 1 000  g/kg — Corrigendum — Article 33


zinc oxide


See Annex V


See Annex V


5.4.2016




28.4.2016


Iron containing intravenous medicinal products — Corrigendum — Article 31


ferric carboxymaltose, iron sucrose complex, sodium ferric gluconate complex, iron(III) isomaltoside complex, iron(III)-hydroxide dextran complex


See Annex VI


See Annex VI


29.4.2016




7.4.2016


Zoledronic acid — Rectificative Decision — PSUSA-3149-201408


zoledronic acid


Not applicable


Not applicable


8.4.2016




25.4.2016


Aripiprazole — PSUSA_234-201507 — Article 107b


aripiprazole


Not applicable


Not applicable


26.4.2016






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I
List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States











Member State EU/EEA


Marketing authorisation holder


Product name


INN


Strength


Pharmaceutical form


Animal species




Austria


Bayer Austria GmbH
Herbststraße 6-10
1160 Wien
Austria


Baytril 25 mg/ml — Injektionslösung für Tiere


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, rabbits, rodents (excluded: guinea pigs, hamster), exotic animals (reptiles, avian species), pigs (piglet, pigs < 30 kg bw)




Austria


Bayer Austria GmbH
Herbststraße 6-10
1160 Wien
Austria


Baytril 50 mg/ml — Injektionslösung für Tiere


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Austria


Bayer Austria GmbH
Herbststraße 6-10
1160 Wien
Austria


Baytril 100 mg/ml — Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium


Baytril 2,5  %


Enrofloxacin


25 mg/ml


Solution for injection


Cats, dogs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium


Baytril Piglet


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium


Baytril 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium


Baytril 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem (Machelen)
Belgium


Baytril Swine


Enrofloxacin


100 mg/ml


Solution for injection


Pigs




Bulgaria


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Байтрил 5 % инжективен разтвор


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Cyprus


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


BAYTRIL INJECTION 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Czech Republic


BAYER s.r.o.
Siemensova 2717/4
155 00 Praha 5
Czech Republic


BAYTRIL 2,5  % (w/v) injekční roztok


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Czech Republic


BAYER s.r.o.
Siemensova 2717/4
155 00 Praha 5
Czech Republic


BAYTRIL 5 % (w/v) injekční roztok


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Denmark


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril Vet.


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cats, cattle, poultry, pigs




Denmark


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril Vet.


Enrofloxacin


100 mg/ml


Solution for injection


Dogs, cats, cattle
poultry, pigs




Finland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril 5 % inj.


Enrofloxacin


50 mg/ml


Solution for injection


Cats, dogs, sheep, cattle, pigs, goats




Finland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril 10 % inj.


Enrofloxacin


100 mg/ml


Solution for injection


Sheep, cattle, pigs, goats




France


Bayer Sante
220 Avenue de la Recherche
59120 Loos
France


BAYTRIL 2,5  %


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




France


Bayer Sante
220 Avenue de la Recherche
59120 Loos
France


BAYTRIL 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




France


Bayer Sante
220 Avenue de la Recherche
59120 Loos
France


BAYTRIL 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Bayer Vital GmbH
Kaiser-Wilhelm-Allee
D-51373 Leverkusen
Germany


Baytril — Das Original — 2,5  % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen


Enrofloxacin


25 mg/ml


Solution for injection


Pig, rabbits, dogs, cats




Germany


Bayer Vital GmbH
Kaiser-Wilhelm-Allee
D-51373 Leverkusen
Germany


Baytril — Das Original — 5 % Injektionslösung


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dogs




Germany


Bayer Vital GmbH
Kaiser-Wilhelm-Allee
D-51373 Leverkusen
Germany


Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


BAYTRIL 2,5  % inj.sol


Enrofloxacin


25 mg/ml


Solution for injection


Dogs




Greece


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


BAYTRIL 5 % inj.sol


Enrofloxacin


50 mg/ml


Solution for injection


Calves, cattle, pigs, dogs




Hungary


Bayer Hungária Kft.
Alkotás u. 50
1123 Budapest
Hungary


Baytril 2,5  % injekció A.U.V.


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, rabbit, dogs, cats, exotic animals (mammals, birds, reptiles)




Hungary


Bayer Hungária Kft.
Alkotás u. 50
1123 Budapest
Hungary


Baytril 5 % injekció A.U.V.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Hungary


Bayer Hungária Kft.
Alkotás u. 50
1123 Budapest
Hungary


Baytril 10 % injekció A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Iceland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, poultry, dogs, cats




Iceland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


100 mg/ml


Solution for injection


Calves, pigs, poultry, dogs, cats




Ireland


Bayer Limited
Animal Health Division
The Atrium
Blackthorn Road
Dublin 18
Ireland


Baytril 2,5  % Solution for Injection


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Ireland


Bayer Limited
Animal Health Division
The Atrium
Blackthorn Road
Dublin 18
Ireland


Baytril 5 % Solution for Injection


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


Bayer Limited
Animal Health Division
The Atrium
Blackthorn Road
Dublin 18
Ireland


Baytril 10 % Solution for Injection


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Italy


Bayer S.p.A.
Viale Certosa, 130
20156 Milano
Italy


Baytril


Enrofloxacin


25 mg/ml and
50 mg/ml


Solution for injection


Cattle, dogs, sheep, goats, cats, rabbits, pigs




Italy


Bayer S.p.A.
Viale Certosa, 130
20156 Milano
Italy


Baytril 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, sheep, goats




Norway


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, cattle, dogs, cats




Norway


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


100 mg/ml


Solution for injection


Pigs, cattle, dogs, cats




Poland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril 2,5  % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Poland


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Portugal


Bayer Portugal S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


BAYTRIL 2,5  % solução injectável


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Portugal


Bayer Portugal S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


Baytril 5 % solução injectável


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cattle, pigs




Portugal


Bayer Portugal S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


Baytril 10 % solução injectável


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


Bayer Health Care AG
D-51368 Leverkusen
Germany


Baytril 5 %


Enrofloxacin


50 mg/ml


solution for injection


Calves, pigs, dogs




Romania


Bayer Health Care AG
D-51368 Leverkusen
Germany


Baytril 10 %


Enrofloxacin


100 mg/ml


solution for injection


Cattle, pigs




Slovakia


Bayer s.r.o.
Litvínovská 609/3
190 21 Praha 9
Czech Republic


Baytril 2,5  %


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Slovakia


Bayer s.r.o.
Litvínovská 609/3
190 21 Praha 9
Czech Republic


Baytril 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Slovenia


Bayer d.o.o.
Bravničarjeva 13
Ljubljana
Slovenia


Baytril® 5 % raztopina za injiciranje


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Slovenia


Bayer d.o.o.
Bravničarjeva 13
Ljubljana
Slovenia


Baytril® 10 % raztopina za injiciranje


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


Bayer Hispania S.L.
Avda Baix LLObregat, 3-5
08970, Saint Joan Despí
Barcelona
Spain


Baytril 2,5  % solución inyectable


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats and other exotic species (rodents, rabbits, cage birds and reptiles (snakes, turtles and iguana))




Spain


Bayer Hispania S.L.
Avda Baix LLObregat, 3-5
08970, Saint Joan Despí
Barcelona
Spain


Baytril 5 % solución inyectable


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cattle, pigs




Spain


Bayer Hispania S.L.
Avda Baix LLObregat, 3-5
08970, Saint Joan Despí
Barcelona
Spain


Baytril 10 % solución inyectable


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Sweden


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril®vet


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, pigs, cattle, cats




Sweden


Bayer Animal Health GmbH
D-51368 Leverkusen
Germany


Baytril®vet


Enrofloxacin


100 mg/ml


Solution for injection


Dogs, pigs, cattle, cats




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


Baytril Piglet 25 mg/ml inspuitbare oplossing


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


BAYTRIL 2,5  % INJEKTIEVLOEISTOF


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


BAYTRIL 5 % INJECTIEOPLOSSING


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


BAYTRIL 5 % INJEKTIEVLOEISTOF


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


BAYTRIL 10 % INJECTIEOPLOSSING


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Bayer BV
Energieweg 1
3641 RT Mijdrecht
The Netherlands


BAYTRIL INJEKTIEVLOEISTOF 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Pigs, cattle




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom


Baytril 2,5  % Solution for Injection


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats and exotic animals (small mammals, reptiles and avian species)




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom


Baytril 5 % Solution for Injection


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury, Berkshire
RG14 1JA
United Kingdom


Baytril 10 % Solution for Injection


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs







ANNEX II
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicants/marketing authorisation holders in the Member States











Member State EU/EEA


Applicant/Marketing Authorisation Holder


Product name


INN


Strength


Pharmaceutical form


Animal species




Austria


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 25, 25 mg/ml Injektionslösung für Hunde, Katzen, Schweine und Kaninchen


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, pigs, rabbits




Austria


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 50, 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (Calves), pigs, dogs




Austria


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 100, 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Austria


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml Injektionslösung für Tiere


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Austria


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Austria


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Enrodexil, 100 mg/ml, Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Austria


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 50 mg/ml Injektionslösung für Kälber, Schweine und Hunde


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Austria


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Austria


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Unisol 100 mg/ml, Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Austria


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Austria


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


BAYTRIL PIGLET


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


BAYTRIL 2,5  %


Enrofloxacin


25 mg/ml


Solution for injection


Cats, dogs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


BAYTRIL 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


BAYTRIL SWINE


Enrofloxacin


100 mg/ml


Solution for injection


Pigs




Belgium


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


BAYTRIL 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle




Belgium


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FENOFLOX 50 MG/ML


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Belgium


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FENOFLOX 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


EMDOKA bvba
John Lijsenstraat 16
B-2321 Hoogstraten
Belgium


FLOXADIL 50 MG/ML


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Belgium


EMDOKA bvba
John Lijsenstraat 16
B-2321 Hoogstraten
Belgium


FLOXADIL 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 25 MG/ML


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Belgium


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 50 MG/ML


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Belgium


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


COLMYC 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Vandenbussche Farma Service
Brusselsesteenweg 396
1980 Eppegem
Belgium


FLOXAVET 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Belgium


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


DORAFLOX 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Belgium


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


UNISOL 100 MG/ML


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Bulgaria


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Байтрил 5 % инжективен разтвор


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Bulgaria


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Ганадексил 5 %


Enrofloxacin


50 mg/ml


Solution for injection


cattle (calves), pigs, dogs




Bulgaria


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Роксацин БГ инжективен


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Bulgaria


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Ценеровиг — 10 ГБ Инж.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, dogs




Bulgaria


Laboratorios Hipra S.A.
Avda. La Selva, 135
17170 Amer
Girona
Spain


Хипралона Енро — И


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Bulgaria


Laboratorios Syva S.A.
Parroco Pablo Diez, 49 — 57
24010 Leon
Spain


Сиваквинол — 100 Инжекционен разтвор


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Bulgaria


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Кинофлокс 100 mg/ml инжекционен разтвор за говеда и свине


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Bulgaria


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Колмик 100 мг/мл инжекционен разтвор за говеда и свине


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Cyprus


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril 5 %, Ενέσιμο διάλυμα για μόσχους, χοίρους και σκύλους


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Czech Republic


Bayer s.r.o.
Siemensova 2717/4
155 00 Praha 5
Czech Republic


BAYTRIL 2,5  % (w/v) injekční roztok
Přípravek s indikačním omezením


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Czech Republic


BAYER s.r.o.
Siemensova 2717/4
155 00 Praha 5
Czech Republic


BAYTRIL 5 % (w/v) injekční roztok
Přípravek s indikačním omezením


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Czech Republic


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml injekční roztok pro psy, kočky a exotická zvířata


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats exotic animals (small mammals, reptiles and birds)




Czech Republic


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml injekční roztok pro skot, prasata, psy a kočky


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Czech Republic


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml injekční roztok pro skot a prasata


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Czech Republic


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 50 mg/ml injekční roztok


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Czech Republic


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 100 mg/ml injekční roztok


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Czech Republic


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 mg/ml injekční roztok


Enrofloxacin


100 mg/ml


Solution for injection


Pigs and calves




Denmark


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril Vet


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cattle, poultry, cats, pigs




Denmark


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril Vet


Enrofloxacin


100 mg/ml


Solution for injection


Dogs, cattle, poultry, cats, pigs




Denmark


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cattle, poultry, cats, pigs




Estonia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Estonia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Estonia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Estonia


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Ganadexil Enrofloxacina 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dogs




Estonia


Laboratorios Hipra S.A.
Avda. La Selva, 135
17170 Amer
Girona
Spain


Hipralona Enro-I


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Estonia


Vetoquinol Biowet Sp z o.o.
13/14 Kosynierów Gdyńskich St.
66-400 Gorzów Wlkp.
Poland


Enrobioflox 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dogs




Finland


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


50 mg/ml


Solution for injection


Cats, dogs, sheep, cattle, pigs, goats




Finland


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox vet


Enrofloxacin


50 mg/ml


Solution for injection


Cats, dogs, cattle, pigs




France


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


ENROCARE 25 MG/ML INJECTABLE POUR CHIENS CHATS ET NAC


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




France


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


ENROCARE 50 MG/ML INJECTABLE POUR BOVINS PORCINS CHIENS ET CHATS


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




France


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


ENROCARE 100 MG/ML INJECTABLE POUR BOVINS ET PORCINS


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




France


Bayer Sante
220 Avenue de la Recherche
59120 LOOS
France


BAYTRIL 2,5  % SOLUTION INJECTABLE


Enrofloxacin


25 mg/ml


Solution for injection


Cattle, pigs, dogs




France


Bayer Sante
220 Avenue de la Recherche
59120 LOOS
France


BAYTRIL 5 % SOLUTION INJECTABLE


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




France


Bayer Sante
220 Avenue de la Recherche
59120 LOOS
France


BAYTRIL 10 % SOLUTION INJECTABLE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




France


BIOLIS
21 Montee De La Garde
69340 Francheville
France


QUINOTRYL 50 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




France


BIOLIS
21 Montee De La Garde
69340 Francheville
France


QUINOTRYL 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




France


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


CHANENRO 50 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS, CHIENS ET CHATS


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




France


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FLOXIBAC 50 MG/ML SOLUTION INJECTABLE POUR BOVINS, PORCINS, CHIENS ET CHATS


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




France


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


CHANENRO 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




France


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FLOXIBAC 100 MG/ML SOLUTION INJECTABLE POUR BOVINS ET PORCINS


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Albrecht GmbH
Hauptstr. 6-8
D-88326 Aulendorf
Germany


Enro-Sleecol 50 mg/ml


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Albrecht GmbH
Hauptstr. 6-8
D-88326 Aulendorf
Germany


Enro-Sleecol 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 25


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, rabbits, dogs, cats




Germany


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 50


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 100


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril — Das Original — 2,5  % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, rabbits, dogs, cats




Germany


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril — Das Original — 5 % Injektionslösung


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Calluna Pharma bvba
Treslong 34
B-2322 Hoogstraaten
Belgium


Enrofloxacin 2,5  % WDT, Injektionslösung


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Germany


Calluna Pharma bvba
Treslong 34
B-2322 Hoogstraaten
Belgium


Enrofloxacin 5 % WDT, Injektionslösung


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Calluna Pharma bvba
Treslong 34
B-2322 Hoogstraaten
Belgium


Enrofloxacin 10 % WDT, Injektionslösung


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Germany


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Enrodexil 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 50 mg/ml Injektionslösung für Rinder (Kälber), Schweine und Hunde


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Roxacin 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Medistar Arzneimittel-Vertrieb GmbH
Lüdinghauser Str. 23
D-59387 Ascheberg
Germany


Enrostar 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Medistar Arzneimittel-Vertrieb GmbH
Lüdinghauser Str. 23
D-59387 Ascheberg
Germany


Enrostar 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Serumwerk Bernburg AG
Hallesche Landstr. 105b
D-06406 Bernburg
Germany


Ursofloxacin 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dog




Germany


Serumwerk Bernburg AG
Hallesche Landstr. 105b
D-06406 Bernburg
Germany


Ursofloxacin 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml Inyectable


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Doraflox 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Unisol


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Germany


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 50 mg/ml Injektionslösung für Rinder, Schweine, Hunde und Katzen


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Germany


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril 2,5  %


Enrofloxacin


25 mg/ml


Solution for injection


Dogs




Greece


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs




Greece


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FLOXIBAC 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Greece


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


FLOXIBAC 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROFLOXACIN/HEALTHCARE


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




Greece


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROFLOXACIN/HEALTHCARE


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Greece


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROFLOXACIN/HEALTHCARE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


COLMYC


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Greece


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


DORAFLOX


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Bayer Hungária Kft.
Alkotás u. 50.
1123 Budapest
Hungary


Baytril 2,5  % injekció A.U.V.


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, rabbits, dogs, cats, exotic animals (mammals, birds, reptiles)




Hungary


Bayer Hungária Kft.
Alkotás u. 50.
1123 Budapest
Hungary


Baytril 5 % injekció A.U.V.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Hungary


Bayer Hungária Kft.
Alkotás u. 50.
1123 Budapest
Hungary


Baytril 10 % injekció A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml injekció szarvasmarha, sertés, kutya és macska részére A.U.V.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Hungary


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml injekció szarvasmarha és sertés részére A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml injekció kutyák, macskák és egzotikus állatok részére A.U.V.


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Hungary


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml injekció szarvasmarha, sertés, kutya és macska részére A.U.V.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Hungary


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml injekció szarvasmarha és sertés részére A.U.V


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 5 % injekció A.U.V.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, sheep, goats




Hungary


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 10 % injekció A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Laboratorios Syva S.A.
Parroco Pablo Diez, 49-57
24010 Leon
Spain


Syvaquinol 100 injekció A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml injekció szarvasmarha és sertés részére A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


DORAFLOX 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Hungary


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


LANFLOX 100 mg/ml injekció szarvasmarhák és sertések számára A.U.V.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Iceland


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril vet.


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, poultry dogs, cats




Iceland


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril vet.


Enrofloxacin


100 mg/ml


Solution for injection


Calves, pigs, poultry dogs, cats




Ireland


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats and exotic animals (small mammals, reptiles and avian species)




Ireland


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs weighing more than 25 kg, dogs, cats




Ireland


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs weighing more than 25 kg




Ireland


Bayer Limited
The Atruim
Blackthorn Road
Dublin 18
Ireland


Baytril 2,5  % Solution for Injection


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Ireland


Bayer Limited
The Atruim
Blackthorn Road
Dublin 18
Ireland


Baytril 5 % Solution for Injection


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


Bayer Limited
The Atruim
Blackthorn Road
Dublin 18
Ireland


Baytril 10 % Solution for Injection


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml Solution for injection for dogs, cats and exotic animals


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Ireland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml Solution for injection for cattle, pigs, dogs and cats


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml Solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Global Vet Health SL
c/Capcanes, no 12-bajos
Poligon Agro-Reus
Reus 43206
Spain


Quinoflox 100 mg/ml solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL 100 mg/ml solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 50 mg/ml solution for injection for calves, pigs and dogs


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Ireland


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 100 mg/ml solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 mg/ml solution for injection for cattle and pig


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Doraflox 100 mg/ml solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Unisol 100 mg/ml solution for injection for cattle and pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Ireland


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 50 mg/ml solution for injection for cattle, pigs, dogs and cats.
Enrofloxacin.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Ireland


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 100 mg/ml solution for injection for cattle and pigs
Enrofloxacin


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Italy


Bayer SpA
Viale Certosa, 130
20156 Milano
Italy


Baytril


Enrofloxacin


25 mg/ml and 50 mg/ml


Solution for injection


Cattle, dogs, sheep, goats, cats, rabbits, pigs




Italy


Bayer SpA
Viale Certosa, 130
20156 Milano
Italy


Baytril 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, sheep, goats




Italy


CEVA Salute Animale
viale Colleoni, 15
20864 Agrate Brianza (MB)
Italy


CEVAFLOX iniettabile, 100 mg/ml, soluzione iniettabile per bovini, ovini, suini.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, sheep




Italy


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


GELLIFLOX 100 mg/ml (or 50 mg/ml) soluzione iniettabile per bovini e suini


Enrofloxacin


100 mg/ml (or 50 mg/ml)


Solution for injection


Cattle, pigs




Italy


Drugs Italia s.r.l.
Via G. Puecher, 8
20037 Paderno Dugnano (MI)
Italy


EFLOXIN soluzione iniettabile


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, sheep




Italy


Fatro s.p.a.
Via Emilia, 285
Ozzano Emilia (BO)
Italy


VALEMAS 10 (or 5) 100 mg/ml (or 50 mg/ml) soluzione iniettabile per bovini, ovi-caprini e suini


Enrofloxacin


100 mg/ml (or 50 mg/ml)


Solution for injection


Cattle, pigs, sheep, goats




Italy


Friulchem
via San Marco, 23
33099 Vivaro (PN)
Italy


TENOTRIL 100 mg/ml soluzione iniettabile per bovini, suini, ovicaprini


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, sheep, goats




Italy


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL 100 mg/ml soluzione iniettabile per bovini e suini


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Italy


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 mg/ml soluzione iniettabile per bovini e suini


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Italy


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


COLMYC 100 mg/ml soluzione iniettabile


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Italy


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


LANFLOX 100 mg/ml soluzione iniettabile per bovini e suini


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Latvia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




Latvia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Latvia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Lithuania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 25 mg/ml, injekcinis tirpalas šunims, katėms ir egzotiniams gyvūnams


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and avian species)




Lithuania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 50 mg/ml, injekcinis tirpalas galvijams, kiaulėms, šunims ir katėms


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Lithuania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 100 mg/ml, injekcinis tirpalas galvijams ir kiaulėms


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Lithuania


Vetoquinol Biowet Sp z o.o.
13/14 Kosynierów Gdyńskich St.
66-400 Gorzów Wlkp.
Poland


ENROBIOFLOX 5 %, injekcinis tirpalas galvijams, kiaulėms ir šunims


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Luxembourg


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 25 mg/ml Injektionslösung für Hunde, katzen und exotische Tiere


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals (small mammals, reptiles and birds)




Luxembourg


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 50 mg/ml Injektionslösung fürRinder, Schweine, Hunde und Katzen


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs > 25 kg, dogs, cats




Luxembourg


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 100 mg/ml Injektionslösung für Rinder und Schweine


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs > 25 kg




Luxembourg


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


Baytril piglet 25 mg/ml


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




Luxembourg


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


Baytril 2,5  %


Enrofloxacin


25 mg/ml


Solution for injection


Cats, dogs




Luxembourg


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


Baytril 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Luxembourg


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


Baytril 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle




Luxembourg


Bayer SA-NV
J.E. Mommaertslaan 14
1831 Diegem
Machelen
Belgium


Baytril Swine 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Pigs




Luxembourg


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml solution injectable pour bovins, porcins, chiens et chats


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Luxembourg


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml solution injectable pour bovins et porcins


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Luxembourg


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc injectable Bovins Porcins


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Malta


Farmcare Ltd
Florence A triq il Fran
Qormi
Malta


Baytril 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Malta


Industrial Veterinaria, S.A
Esmeralda, 19,
08950 Esplugues de Llobreget
Barcelona
Spain


Ganadexil Enrofloxacino 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Malta


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Roxacin injection


Enrofloxacin


100 mg/ml


Solution for injection


Pigs




Malta


Laboratorios Syva S.A.
Parroco Pablo Diez, 49-57
24010 Leon
Spain


Syvaquinol 25 %


Enrofloxacin


25 mg/ml


Solution for injection


Calves, piglets, dogs




Malta


Laboratorios Syva S.A.
Parroco Pablo Diez, 49-57
24010 Leon
Spain


Syvaquinol 100 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Norway


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


25 mg/ml


Solution for injection


Pigs, cattle, dogs, cats




Norway


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril vet


Enrofloxacin


100 mg/ml


Solution for injection


Pigs, cattle, dogs, cats




Norway


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Poland


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril 2,5  % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Poland


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Poland


Biowet Puławy Sp. z o.o.
2 Arciucha Str.
24-100
Puławy
Poland


Enflocyna inj, 100 mg/ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Poland


Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.
6 Grójecka Str.
05-651 Drwalew
Poland


Enrofloksacyna 10 % inj., 100 mg/ml roztwór do wstrzykiwań dla bydła


Enrofloxacin


100 mg/ml


Solution for injection


Cattle




Poland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml roztwór do wstrzykiwań dla psów, kotów i zwierząt egzotycznych


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




Poland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg roztwór do wstrzykiwań dla bydła, świń, psów i kotów


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Poland


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Poland


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Enrodexil, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Poland


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Poland


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Roxacin, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Poland


PFO ‘Vetos-Farma’ Sp. z o.o.
21 Dzierżoniowska Str.
58-260
Bielawa
Poland


Enrofloxacyna 5 % iniekcja, enrofloxacyna 5 g/100 ml, roztwór dla bydła, świń, psów i kotów


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Poland


PFO ‘Vetos-Farma’ Sp. z o.o.
21 Dzierżoniowska Str.
58-260
Bielawa
Poland


Enrofloxacyna 10 % iniekcja, enrofloksacyna 10 g/100 ml, roztwór do wstrzykiwań dla bydła, świń, psów i kotów


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Poland


Pharmagal, s.r.o.
Murgasova 5
949 01, Nitra
Slovakia


Enrogal 50 mg/ml roztwór do wstrzykiwań


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Poland


Przedsiębiorstwo Wielobranżowe VET-AGRO Sp. z o.o.
32 Gliniana Str.
20-616
Lublin
Poland


Enrocin 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Poland


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Poland


Vetoquinol Biowet Sp z o.o.
13/14 Kosynierów Gdyńskich St.
66-400 Gorzów Wlkp.
Poland


Enrobioflox 5 % Injectio, 50 mg/ml roztwór do wstrzykiwań dla świń, bydła i psów


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Poland


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Lanflox, 100 mg/ml roztwór do wstrzykiwań dla bydła i świń


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Bayer PORTUGAL S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


BAYTRIL 2,5  % solução injectável


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Portugal


Bayer PORTUGAL S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


Baytril 5 % solução injectável


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, cattle and pigs




Portugal


Bayer PORTUGAL S.A.
Rua Quinta do Pinheiro, 5
2794-003 Carnaxide
Portugal


Baytril 10 % solução injectável


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml solução injectável para bovinos, suínos, cães e gatos


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Portugal


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 50 mg/ml solução injetável para bovinos, suínos, cães e gatos


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Portugal


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 100 mg/ml solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


ESTEVE FARMA, LDA
Av. Do Forte, 3
Edifício Suécia II
Piso 4A
2794-044 Carnaxide
Portugal


ALSIR 25 mg/ml solução injectável para Cães e Gatos


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Portugal


ESTEVE FARMA, LDA
Av. Do Forte, 3
Edifício Suécia II
Piso 4A
2794-044 Carnaxide
Portugal


ALSIR 50 Mmg/ml Solução Injectável


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Portugal


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml Solução injectável para cães, gatos e animais exóticos


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic Animals (small mammals, reptiles and avian species)




Portugal


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml Solução injectável para bovinos, suínos, cães e gatos


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Portugal


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Global Vet Health SL
c/Capcanes, no 12-bajos
Poligon Agro-Reus
Reus 43206
Spain


Quinoflox 100 mg/ml solução injetável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 mg/ml solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml Solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


LANFLOX 100 mg/ml solução injectável para bovinos e suínos.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Portugal


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


ENRODEXIL 100 mg/ml solução injectável para bovinos e suínos


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


CENAVISA SA LABORATORIOS
Cami Pedra Estela s/n
43205 REUS
Spain


CENAMICINA 10 PLUS


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs, dogs




Romania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 25 mg/ml


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




Romania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 50 mg/ml


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Romania


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


ENROTRON 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pig




Romania


Global Vet Health SL
c/Capcanes, no 12-bajos
Poligon Agro-Reus
Reus 43206
Spain


QUINOFLOX 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


GANADEXIL ENROFLOXACINA
5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs,




Romania


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL 50 mg/ml


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, goats, sheep, dogs




Romania


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


Laboratorios Hipra S.A.
Avda. La Selva, 135
17170 Amer
Girona
Spain


HIPRALONA ENRO I


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs




Romania


Laboratorios Syva S.A.
Parroco Pablo Diez, 49-57
24010 Leon
Spain


SYVAQUINOL 100 injectable


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


LABORATORIOS VELVIAN S.L
C/Vitoria 9, 2 B
09004
Burgos
Spain


ENRODEXIL 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


PASTEUR
Filiala Filipesti SRL
Str. Principala nr. 944
Filipestii de Padure
Jud. Prahova
Romania


Enrofloxacina 5 % injectable solution


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, sheep, goats, pigs, dogs, cats




Romania


PASTEUR
Filiala Filipesti SRL
Str. Principala nr. 944
Filipestii de Padure
Jud. Prahova
Romania


Enrofloxacina 10 % injectable solution


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, sheep, goats, pigs, dogs, cats




Romania


S.C. ROMVAC COMPANY S.A.
Şos. Centurii, nr. 7
Voluntari
Romania


Enrofloxarom 5 %


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, sheep, pigs, dogs




Romania


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml inyectable solution


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Romania


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


DORAFLOX 100 mg/ml


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovakia


Bayer s.r.o.
Litvínovská 609/3
190 21 Praha 9
Czech Republic


Baytril 2,5  % inj. ad us. vet.


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Slovakia


Bayer s.r.o.
Litvínovská 609/3
190 21 Praha 9
Czech Republic


Baytril 5 % (w/v) injekčný roztok


Enrofloxacin


50 mg/ml


Solution for injection


Dogs, pigs, calves




Slovakia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml injekčný roztok pre psy, mačky a exotické živočíchy


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




Slovakia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml injekčný roztok pre hovädzí dobytok, ošípané, psy a mačky


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




Slovakia


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml injekčný roztok


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovakia


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 5 % inj. ad us. vet.


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, sheep, goats, pigs, dogs




Slovakia


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 10 % inj. ad us. vet.


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovakia


Laboratorios Hipra S.A.
Avda. La Selva, 135
17170 Amer
Girona
Spain


Hipralona Enro — I 50 mg/ml injekčný roztok


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs




Slovakia


Pharmagal, s.r.o.
Murgasova 5
949 01, Nitra
Slovakia


Enrogal 50 mg/ml injekčný roztok


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Slovenia


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


Enrotron 25, 25 mg/ml raztopina za injiciranje za pse, mačke, prašiče in kunce


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, pigs, rabbits




Slovenia


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


ENROTRON 50, 50 mg/ml raztopina za injiciranje za govedo (teleta), prašiče in pse


Enrofloxacin


50 mg/ml


Solution for injection


Cattle (calves), pigs, dogs




Slovenia


aniMedica GmbH
Im Südfeld 9
48308 Senden-Bösensell
Germany


ENROTRON 100, 100 mg/ml raztopina za injiciranje za govedo in prašiče


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovenia


Bayer d.o.o.
Bravničarjeva 13
Ljubljana
Slovenia


Baytril® 5 % raztopina za injiciranje


Enrofloxacin


50 mg/ml


Solution for injection


Calves, pigs, dogs




Slovenia


Bayer d.o.o.
Bravničarjeva 13
Ljubljana
Slovenia


Baytril® 10 % raztopina za injiciranje


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovenia


GENERA Slovenia d.o.o.
Dunajska 51
1000 Ljubljana
Slovenia


VETOFLOK 10 % raztopina za injiciranje


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovenia


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL 50 mg/ml raztopina za injiciranje za govedo, ovce, koze, prašiče in pse


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, sheep, goats, pigs, dogs




Slovenia


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROX 100 mg/ml raztopina za injiciranje za govedo in prašiče


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Slovenia


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL 100 mg/ml raztopina za injiciranje za govedo in prašiče


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


Hifarmax, Produtos e serviços veterinários, Lda
Av. Marechal Craveiro Lopes no 96 R/C
Dto 2775-696 Carcavelos
Portugal


ENROCILL 50 mg/ml solución inyectable para bovino, porcino y perros


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Spain


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


ENRODEXIL 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


ROXACIN 100 mg/ml SOLUCION INYECTABLE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


Laboratorios Dr. Esteve, S.A.
Avda. Mare de Déu de Montserrat, 221
08041 Barcelona
Spain


ALSIR 2,5  % SOLUCION INYECTABLE


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




Spain


Laboratorios Dr. Esteve, S.A.
Avda. Mare de Déu de Montserrat, 221
08041 Barcelona
Spain


ALSIR 5 % SOLUCION INYECTABLE


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




Spain


Laboratorios Dr. Esteve, S.A.
Avda. Mare de Déu de Montserrat, 221
08041 Barcelona
Spain


ALSIR 100 mg/ml SOLUCION INYECTABLE PARA BOVINO Y PORCINO


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


QUINOLCEN 100 mg/ml SOLUCION INYECTABLE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


FLOXAVEX 100 mg/ml SOLUCION INYECTABLE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Spain


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


LANFLOX 100 mg/ml SOLUCION INYECTABLE


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




Sweden


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril® vet.


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, pigs, cattle, cats




Sweden


Bayer Animal Health GmbH
Kaiser-Wilhelm-Allee 50
51368 Leverkusen
Germany


Baytril® vet.


Enrofloxacin


100 mg/ml


Solution for injection


Dog, pigs, cattle, cats




Sweden


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox vet


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 25 mg/ml, oplossing voor injectie voor honden, katten en exotische dieren


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, exotic animals




The Netherlands


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




The Netherlands


Animalcare Group plc.
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Floxadil 100 mg/ml, oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


BAYTRIL 2,5  % INJEKTIEVLOEISTOF


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


Baytril Piglet 25 mg/ml inspuitbare oplossing


Enrofloxacin


25 mg/ml


Solution for injection


Pigs




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


BAYTRIL 5 % INJEKTIEVLOEISTOF


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


BAYTRIL 5 % INJECTIEOPLOSSING


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, dogs, pigs




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


BAYTRIL INJEKTIEVLOEISTOF 10 %


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Bayer B.V.
Energieweg 1
3641 RT Mijdrecht
Netherlands


BAYTRIL 10 % INJECTIEOPLOSSING


Enrofloxacin


100 mg/ml


Solution for injection


Pigs, cattle




The Netherlands


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml Oplossing voor injectie


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




The Netherlands


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml Oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml, oplossing voor injectie


Enrofloxacin


25 mg/ml


Solution for injection


Dogs, cats, cage birds, reptiles




The Netherlands


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml, oplossing voor injectie voor runderen, varkens, honden en katten


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




The Netherlands


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml, oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL Oplossing voor injectie 50 mg/ml voor kalveren, varkens en honden


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs




The Netherlands


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


ENROXIL 100 MG/ML SOLUTION FOR INJECTION


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Laboratorios Calier, S.A.
c/Barcelonès, 26 (Pla del Ramassà)
08520 Les Franqueses del Valles
Barcelona
Spain


Roxacin 100 mg/ml, oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Romikim Farma SL
Gran Via Carlos III, 98,6
8027 Barcelona
Spain


Enrodexil 100 mg/ml oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


SP Veterinaria SA
Ctra. Reus Vinyols km 4.1
43330 Riudoms
Tarragona
Spain


Colmyc 100 mg/ml injectieoplossing voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Doraflox 100 mg/ml, oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Unisol 100 mg/ml, oplossing voor injectie voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




The Netherlands


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox Oplossing voor injectie 50 mg/ml voor runderen, varkens, honden en katten


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, pigs, dogs, cats




The Netherlands


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox Oplossing voor injectie 100 mg/ml voor runderen en varkens


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Animalcare Ltd
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals


Enrofloxacin


25 mg/ml


Solution for injection


Cage birds, cats, dogs, exotic animals, reptiles, small mammals




United Kingdom


Animalcare Ltd
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, pigs




United Kingdom


Animalcare Ltd
10 Great North Way
York Business Park
Nether Poppleton
York
YO26 6RB
United Kingdom


Enrocare 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom


Baytril 2,5  % Solution for Injection


Enrofloxacin


25 mg/ml


Solution for injection


Cage birds, cats, dogs, exotic animals, reptiles, small mammals




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom


Baytril 5 % Solution for Injection


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, pigs




United Kingdom


Bayer plc
Animal Health Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom


Baytril 10 % Solution for Injection


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, pigs




United Kingdom


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, Pigs




United Kingdom


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea
Co. Galway
Ireland


Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 25 mg/ml Solution for Injection for Dogs, Cats and Exotic Animals


Enrofloxacin


25 mg/ml


Solution for injection


Cage birds, cats, dogs, exotic animals, reptiles, small mammals




United Kingdom


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, pigs




United Kingdom


FORTE Healthcare Limited
Cougar Lane
Naul
Co. Dublin
Ireland


Enrotron 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Global Vet Health SL
c/Capcanes, no 12-bajos
Poligon Agro-Reus
Reus 43206
Spain


Quinoflox 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Industrial Veterinaria SA
C/Esmeralda 19-21
08950 Esplugues de Llobregat
Barcelona
Spain


Enrodexil 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 50 mg/ml Solution for Injection for Calves, Pigs and Dogs


Enrofloxacin


50 mg/ml


Solution for injection


Cattle, dogs, pigs




United Kingdom


Krka d.d.
Novo mesto
Smarjeska cesta 6
8501 Novo Mesto
Slovenia


Enroxil 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Doraflox 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Vetpharma Animal Health, S.L.
Les Corts 23.
08028 Barcelona
Spain


Unisol 100 mg/ml Solution for Injection for Cattle and Pigs


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs




United Kingdom


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats Enrofloxacin


Enrofloxacin


50 mg/ml


Solution for injection


Cats, cattle, dogs, pigs




United Kingdom


Virbac S.A.
1ére Avenue L.I.D. 2065m
06516 Carros Cedex
France


Powerflox 100 mg/ml Solution for Injection for Cattle and Pigs Enrofloxacin


Enrofloxacin


100 mg/ml


Solution for injection


Cattle, pigs







ANNEX III
List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holder in the member states











Member State
EU/EEA


Marketing Authorisation Holder


Invented Name


Strength


Pharmaceutical Form


Route of Administration


Content (concentration)




Austria


Roche Austria GmbH
Engelhorngasse 3
1211 Vienna
Austria


Cymevene ‘Roche’ 500 mg — Trockensubstanz zur Infusionsbereitung


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Belgium


N.V. Roche S.A.
Rue Dante 75
B-1070 Brussels
Belgium


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Bulgaria


Roche Bulgaria EOOD
16, Byalo pole Str.
1618 Sofia,
Bulgaria


Симевен 500 mg прах за инфузионен разтвор


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Croatia


Roche d.o.o.
Ulica grada Vukovara 269a
10 000 Zagreb
Croatia


Cymevene 500 mg prašak za otopinu za infuziju


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Cyprus


G. A. Stamatis & Co. Ltd
27, Andreas Araouzos
P.O. Box 21305
1506 Nicosia
Cyprus


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Czech Republic


Roche s.r.o.
Dukelských hrdinů 567/52,
170 00 Praha 7
Czech Republic


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Denmark


Roche A/S
Industriholmen 59
2650 Hvidovre
Denmark


Cymevene


500 mg


Powder for concentrate for infusion for solution


Intravenous use


50 mg/ml




Estonia


Roche Eesti OÜ
Lõõtsa 2,
11415 Tallinn,
Estonia


Cymevene


500 mg


Powder for concentrate for solution for infusion


Intravenous use


50 mg/ml




Finland


Roche Oy
Klovinpellontie 3
P.O. Box 12
02181 Espoo
Finland


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




France


Roche
30, cours de l’Ile Seguin
92650 Boulogne
Billancourt Cedex
France


CYMEVAN 500 mg, lyophilisat pour usage parentéral (perfusion)


500 mg


Lyophilisate for parenteral use (infusion)


Intravenous use


50 mg/ml




Germany


Roche Pharma AG
Emil-Barell-Straße 1
79639 Grenzach-Wyhlen
Germany


Cymeven® i. v.


500 mg


Powder for concentrate for solution for infusion


Intravenous use


50 mg/ml




Greece


Roche Hellas A.E.
4, Alamanas & Delfon str.
151 25 Maroussi
Greece


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Hungary


Roche (Hungary) Ltd
Edison str 1.
Budaörs H-2040
Hungary


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Iceland


Roche A/S
Industriholmen 59
2650 Hvidovre
Denmark


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Ireland


Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom


Cymevene 500 mg Powder for Concentrate for Solution for Infusion


500 mg


Powder for Concentrate for Solution for Infusion


Intravenous use


50 mg/ml




Italy


Roche S.p.A.,
Piazza Durante 11
Milan
Italy


Citovirax


500 mg


Powder for concentrate for solution for infusion


Intravenous use


50 mg/ml




Lithuania


UAB ‘Roche Lietuva’
J.Jasinskio str. 16B
LT-03163 Vilnius
Lithuania


Cymevene


500 mg


Powder for concentrate for solution for infusion


Intravenous use


50 mg/ml




Luxembourg


N.V. Roche S.A.
Rue Dante 75
B-1070 Brussels
Belgium


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




The Netherlands


Roche Nederland B.V.
Beneluxlaan 2a
3446 GR Woerden
The Netherlands


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Norway


Roche Norge AS
Brynsengfaret 6B
Postboks 6610 Etterstad
0607 Oslo
Norway


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Poland


Roche Polska Sp. z o.o.
ul. Domaniewska 39 B
02-672 Warsaw,
Poland


Cymevene


500 mg


Powder for concentrate for solution for infusion


Intravenous use


50 mg/ml




Portugal


Roche Farmacêutica Química, Lda.
Estrada Nacional 249-1
2720-413 Amadora
Portugal


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg




Romania


Roche România SRL
Piata Presei Libere, Nr. 3-5, Clădirea City Gate — Turnul de Sud, Etajele 4A, 5 şi 6, Sector 1, Bucureşti România


Cymevene 500 mg pulbere pentru soluţie perfuzabilă


500 mg


powder for solution for infusion


Intravenous use


50 mg/ml




Slovak Republic


Roche Slovensko s.r.o.
Cintorínska 3/A
Bratislava 811 08
Slovak Republic


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Spain


Roche Farma, S.A.
Eucalipto no 33,
28016 Madrid
Spain


Cymevene 500 mg polvo para solución para perfusión


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




Sweden


Roche AB
Liljeholmsstranden 5
Box 47327
100 74 Stockholm
Sweden


Cymevene


500 mg


Powder for solution for infusion


Intravenous use


50 mg/ml




United Kingdom


Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom


Cymevene powder for infusion


500 mg


Powder for Infusion


Intravenous use


50 mg/ml







ANNEX IV
List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States











Member State EU/EEA


Applicant
company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration


Content (concentration)




Bulgaria


UAB ‘VVB’
9-ojo Forto str. 70
LT-48179 Kaunas
Lithuania


Тобрамицин ВBБ


300 mg/5 ml


nebuliser solution


inhalation use


6 %




Estonia


UAB ‘VVB’
9-ojo Forto str. 70
LT-48179 Kaunas
Lithuania


Tobramycin VVB


300 mg/5 ml


nebuliser solution


inhalation use


6 %




Hungary


UAB ‘VVB’
9-ojo Forto str. 70
LT-48179 Kaunas
Lithuania


Tobramycin VVB


300 mg/5 ml


nebuliser solution


inhalation use


6 %




Latvia


UAB ‘VVB’
9-ojo Forto str. 70
LT-48179 Kaunas
Lithuania


Tobramycin VVB
300 mg/5 ml šķīdums izsmidzināšanai


300 mg/5 ml


nebuliser solution


inhalation use


6 %




Lithuania


UAB ‘VVB’
9-ojo Forto str. 70
LT-48179 Kaunas
Lithuania


Tobramycin VVB


300 mg/5 ml


nebuliser solution


inhalation use


6 %




Poland


UAB ‘VVB’
9-ojo Forto str. 70
LT-48179 Kaunas
Lithuania


Tobramycin VVB


300 mg/5 ml


nebuliser solution


inhalation use


6 %




Romania


UAB ‘VVB’
9-ojo Forto str. 70
LT-48179 Kaunas
Lithuania


Tobramycin VVB


300 mg/5 ml


nebuliser solution


inhalation use


6 %







ANNEX V
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States












Member State
(EU/EEA)


Applicant


Product name


INN


Strength


Pharmaceutical
form


Animal species


Route of
administration




Austria


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Belgium


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Bulgaria


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Cyprus


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Czech Republic


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Denmark


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Estonia


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




France


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Germany


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Greece


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Hungary


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Ireland


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Italy


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Latvia


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Lithuania


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Luxembourg


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Malta


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




The Netherlands


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Poland


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Portugal


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Romania


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Slovakia


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Slovenia


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




Spain


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.




United Kingdom


Huvepharma NV Uitbreidingstraat 80
2600 Antwerp
Belgium


Gutal 1 000  g/kg premix for medicated feeding stuff for piglets


Zinc oxide


1 000  g/kg


Premix for medicated feeding stuff


Piglet (weaned piglets)


For incorporation into dry feed at the registered mill. Oral use only.







The annexes to Commission Implementing Decision C(2013)5970 final shall read as attached below.
ANNEX VI
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States











Member State
(in EEA)


Marketing authorisation holder


INN


Invented name


Strength


Pharmaceutical form


Route of administration




Austria


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


CosmoFer 50 mg/ml Injektionslösung und Infusionslösung


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Austria


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92200 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject 50 mg Eisen/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung


50 mg/ml


Solution for injection/infusion


Intravenous use




Austria


Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37
DE-58638 Iserlohn
Germany


Iron sucrose complex


FerMed 100 mg/5 ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Austria


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic 20 mg/ml Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Austria


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monofer 100 mg/ml Injektions- oder Infusionslösung


100 mg/ml


Solution for injection/infusion


Intravenous use




Austria


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92200 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer 20 mg/ml — Injektionslösung oder Konzentrat zur Herstellung einer Infusionslösung


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Belgium


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use




Belgium


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monover


100 mg/ml


Solution for injection/infusion


Intravenous use




Belgium


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Belgium


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric Carboxymaltose


Injectafer


50,00  mg/ml


Solution for injection/infusion


Intravenous use




Bulgaria


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Bulgaria


Pharmalog AG,
33 Cherni vrah blvd.,
1421 Sofia
Bulgaria


Iron sucrose complex


Idafer


20 mg/ml


Solution for injection


Intravenous use




Bulgaria


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection


Intravenous use




Bulgaria


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




Cyprus


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


ferric carboxymaltose


FERINJECT SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML


50 mg/ml


Solution for injection/infusion


Intravenous use




Cyprus


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


MONOFER SOLUTION FOR INJECTION OR INFUSION 100 MG/ML


100 mg/ml


Solution for injection/infusion


Intravenous use




Cyprus


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


COSMOFER SOLUTION FOR INJECTION OR INFUSION 50 MG IRON/ML


50 mg/ml


Solution for injection/infusion


Intravenous use




Cyprus


The Star Medicines Importers & co ltd,
9A Loukis Akritas Street,
P.O.box 50151,
3601 Lemesos, Cyprus


Iron sucrose complex


VENOFER INJECTION 100 MG IRON/5 ML


100 mg/5 ml


Solution for injection


Intravenous use




Cyprus


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


FERROLOGIC SOLUTION FOR INJECTION/CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML


20 mg/ml


Solution for injection/infusion


Intravenous use




Czech Republic


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


VENOFER


20 mg/ml


Solution for injection


Intravenous use




Czech Republic


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


FERROLOGIC 20 MG/ML


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Czech Republic


PHARMABIDE LTD
20, Lakonias str,
15234 Halandri
Athens — Greece


Iron sucrose complex


IRON SUCROSE PHARMABIDE 20 MG/ML


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Czech Republic


Orion Corporation,
Orionintie 1,
FI-02200 Espoo,
Finland


Iron sucrose complex


FERION 20 MG/ML


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Czech Republic


Sanofi-Aventis, s.r.o.
Evropská 846/176a
160 00 Praha 6
Czech Republic


sodium ferric gluconate complex


FERRLECIT


12,5  mg/ml


Solution for injection


Intravenous use




Czech Republic


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


ferric carboxymaltose


FERINJECT


50 mg/ml


Solution for injection/infusion


Intravenous use




Denmark


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use




Denmark


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Denmark


Orion Corporation,
Orionintie 1,
FI-02200 Espoo,
Finland


Iron sucrose complex


Ferion


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Denmark


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Denmark


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Jerndextran ‘Pharmacosmos’


50 mg/ml


Solution for injection/infusion


Intravenous use




Denmark


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


MonoFer


100 mg/ml


Solution for injection/infusion


Intravenous use




Denmark


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Estonia


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Estonia


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic 20 mg/ml


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Estonia


Orion Corporation,
Orionintie 1,
FI-02200 Espoo,
Finland


Iron sucrose complex


Ferion


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Estonia


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Estonia


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




Estonia


Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia


Iron (III) hydroxide dextran complex


Ferrum Lek


50 mg/ml


Solution for injection


Intramuscular use




Finland


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Finland


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Finland


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Finland


Alternova A/S
Lodshusvej 11
4230 Skaelskoer
Denmark


Iron sucrose complex


Venotrix


20 mg/ml


Concentrate for solution for infusion/solution for injection


Intravenous use




Finland


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use




Finland


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




France


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric Carboxymaltose


FERINJECT 50 mg/ml, solution injectable/pour perfusion


50 mg/ml


Solution for injection/infusion


Intravenous use




France


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


VENOFER 20 mg/ml, solution injectable


20 mg/ml


Solution for injection


Intravenous use




France


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


FERRISAT 50 mg/ml, solution injectable ou pour perfusion


50 mg/ml


Solution for injection/infusion


Intravenous use




France


Pharmaki Generics Ltd
5 Bourlet Close
W1W 7BL London
United Kingdom


Iron sucrose complex


FER ACTAVIS 100 mg/5 ml, solution injectable


100 mg/5 ml


Solution for injection


Intravenous use




France


IBD3 Pharma Consulting
Immeuble l’Orient
10, place Charles Béraudier
69003 Lyon
France


Iron sucrose complex


FER IBD3 PHARMA CONSULTING 100 mg/5 ml, solution à diluer pour perfusion


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




France


Mylan SAS
117, allée des Parcs
69800 Saint-Priest
France


Iron sucrose complex


FER MYLAN 100 mg/5 ml, solution à diluer pour perfusion


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




France


SANDOZ
49, avenue Georges Pompidou
92300 Levallois-Perret France


Iron sucrose complex


FER SANDOZ 100 mg/5 ml, solution à diluer pour perfusion


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




France


TEVA SANTE
110, Esplanade du Général de Gaulle
92931 Paris La Défense Cedex
FRANCE


Iron sucrose complex


FER TEVA PHARMA 100 mg/5 ml, solution injectable (IV)


100 mg/5 ml


Solution for injection


Intravenous use




Germany


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic 20 mg/ml Injektionslösung/Konzentrat zur Herstellung einer Infusionslösung


1 709  mg/5 ml


Concentrate for solution for infusion/solution for injection


Intravenous use




Germany


Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37
DE-58638 Iserlohn
Germany


Iron sucrose complex


FerMed


1 563  — 1 887  mg/5 ml


Concentrate for solution for infusion/solution for injection


Intravenous use




Germany


Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37
DE-58638 Iserlohn
Germany


Iron sucrose complex


Nefro-Fer


1 563  — 1 887  mg/5 ml


Solution for injection


Intravenous use




Germany


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monofer 100 mg/ml Lösung zur Injektion/Infusion


377-465 mg/ml


Solution for injection/infusion


Intravenous use




Germany


Sanofi-Aventis Deutschland GmbH
Brüningstrasse 50,
D-65926 Frankfurt am Main Germany


sodium ferric gluconate complex


Ferrlecit 40 mg


1 288,9  mg/3,2  ml


Solution for injection


Intravenous use




Germany


Sanofi-Aventis Deutschland GmbH
Brüningstrasse 50,
D-65926 Frankfurt am Main Germany


sodium ferric gluconate complex


Ferrlecit 62,5  mg


2 013,9  mg/5 ml


Solution for injection


Intravenous use




Germany


Pharmacosmos A/S
Roervangsvei 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


CosmoFer 50 mg/ml Injektionslösong und Infusionslösung


312,5  mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Germany


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose complex


FERINJECT 50 mg Eisen/ml Injektions- und Infusionslösung


180 mg/ml


Solution for injection/infusion


Intravenous use




Germany


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer 20 mg FR/ml Injektionslösung


2 700  mg/5 ml


Concentrate for solution for infusion/solution for injection


Intravenous use




Greece


Medicus SA
Valaoritou 10
Metamorfosi
Attikis 14452
Greece


Iron sucrose complex


REOXYL


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece


Vianex S.A.
Tatoiou Street
Nea Erythrea 14671
Greece


Iron sucrose complex


INTRAFER


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece


Alapis ABEE
Aftokratoros Nikolaou 2
Athens 17671
Greece


Iron sucrose complex


FAREMIO


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece


Intermed ABEE
Kalyftaki 27
Athens 14564
Greece


Iron sucrose complex


DEXTRIFER-S


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


VENOFER


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece


Demo ABEE
21ST Km National Highway
Athens-Lamia, 14565
Greece


Iron (III) hydroxide dextran


COSMOFER


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Greece


Rafarm AEBE
Korinthou 12,
N. Psychiko, 15451
Greece


Iron sucrose complex


FERROVIN


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece


Nephrotech S.A.
Parnithos 44
Metamorfosi Attikis 14452
Greece


Iron sucrose complex


SUCRO-FER


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece


Uni-Pharma Kleon Tseitis
Pharmaceutical Laboratories
14KM National Highway
Athens-Lamia
Kifissia 14564
Greece


Iron sucrose complex


HEMAFER-S


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




Greece


Verisfield (UK) Ltd, U.K.
41 Chalton street
London, NW1 1JD
United Kingdom


Iron sucrose complex


NEPHROFEROL


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece


HELP ABEE
Valaoritou 10
Metamorfosi
Attikis, 14452
Greece


Iron sucrose complex


FERRINEMIA


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece


Specifar AEBE
28th October Street 1
Agia Barbara 12351
Greece


Iron sucrose complex


ALVOFER


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




Greece


Alet Pharmaceuticals
M. Alexander 121,
Agia Varvara, 12351
Greece


Iron sucrose complex


SUCROVEN


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




Greece


Target Pharma Ltd
Menandrou 54
Athens 10431
Greece


Iron sucrose complex


IRONCROSE


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Greece


HELP ABEE
Valaoritou 10
Metamorfosi
Attikis, 14452
Greece


Iron (III) hydroxide dextran complex


IRONATE


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Greece


Demo ABEE
21st km National Highway
Athens-Lamia, 14565
Greece


Iron(III) isomaltoside complex


MONOFER


100 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Greece


Viofar EPE
Ethnikis Antistaseos & Trifyllias,
Aharnai, 13671
Greece


Iron sucrose complex


VENIRON


100 mg/5 ml


Concentrate for solution for infusion


Intravenous use




Greece


Medicus SA
Valaoritou 10
Metamorfosi
Attikis 14452
Greece


Iron (III) hydroxide dextran complex


IRON (III)-HYDROXIDE DEXTRAN COMPLEX/BIOMEDIC LABORATORIES


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Hungary


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Hungary


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection/infusion


Intravenous use




Hungary


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection/infusion


Intravenous use




Hungary


Sanofi-Aventis Zrt
Tó utca 1-5,
1045 Budapest
Hungary


Sodium ferric gluconate complex


Ferrlecit


12,5  mg/ml


Solution for injection


Intravenous use




Iceland


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Iceland


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for infusion


Intravenous use




Iceland


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection


Intravenous use




Ireland


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


CosmoFer 50 mg/ml solution for infusion and injection


50 mg/ml


Solution for injection/infusion


Intravenous use




Ireland


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monover 100 mg/ml solution for injection/infusion (ampoules)


100 mg/ml


Solution for injection/infusion


Intravenous use




Ireland


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monover 100 mg/ml solution for injection/infusion (vials)


100 mg/ml


Solution for injection/infusion


Intravenous use




Ireland


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, ampoule


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Ireland


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


ferric carboxymaltose


FERINJECT 50 mg iron/ml solution for injection/infusion


50 mg/ml


Solution for injection/infusion


Intravenous use




Ireland


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex)


Venofer 20 mg iron/ml solution for injection or concentrate for solution for infusion, vial


20 mg/ml


Solution for injection/infusion


Intravenous use




Ireland


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


FerroLogic 20 mg/ml solution for injection/concentrate for solution for infusion


20 mg/ml


Solution for injection


Intravenous use




Italy


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


ferric carboxymaltose


FERINJECT


50 mg/ml


Solution for injection/infusion


Intravenous use




Italy


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


FERRO SACCARATO FME


20 mg/ml


Concentrate for solution for infusion/solution for injection


Intravenous use




Italy


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


VENOFER


20 mg/ml


Solution for injection


Intravenous use




Italy


Sanofi-Aventis SPA
Viale Luigi Bodio, 37/B
20158 Milano
Italy


sodium ferric gluconate complex


FERLIXIT


62,5  mg/5 ml


Oral solution or solution for infusion


Oral use
Intravenous use




Latvia


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Latvia


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection


Intravenous use




Latvia


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


FerroLogic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Latvia


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


CosmoFer


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Latvia


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




Lithuania


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Lithuania


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection


Intravenous use




Lithuania


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Lithuania


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




Lithuania


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Ferric (III) hydroxide dextran complex


CosmoFer


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Luxembourg


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


Injectafer-50 mg/l


50 mg/ml


Solution for injection


Intravenous use




Luxembourg


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Cosmofer-50 mg/ml


50 mg/ml


Solution for injection


Intravenous use




Luxembourg


Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37
DE-58638 Iserlohn
Germany


Iron sucrose complex


Fermed-100 mg/5 ml


100 mg/5 ml


Solution for perfusion


Intravenous use




Luxembourg


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic-20 mg/ml


20 mg/ml


Solution for perfusion


Intravenous use




Malta


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92200 Neuilly-sur-Seine
France


ferric carboxymaltose


FERINJECT 50 mg iron/ml solution for injection/infusion


50 mg/ml


Solution for injection/infusion


Intravenous use




Malta


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex.


Ferrologic 20 mg/ml solution for injection/concentrate for solution for infusion


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Norway


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Parenteral use




Norway


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Parenteral use




Norway


Orion Corporation,
Orionintie 1,
FI-02200 Espoo,
Finland


Iron sucrose complex


Ferion


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Parenteral use




Norway


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Parenteral use




Norway


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Parenteral use




Norway


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Uniferon


200 mg/ml


Solution for injection


Parenteral use




Norway


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Parenteral use




Poland


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


CosmoFer


50 mg/ml


Solution for injection/infusion


Intravenous use




Poland


VIFOR France SA
123 Rue Jules Guesde
92200 Neuilly-sur-Seine
France


ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection


Intravenous use




Poland


VIFOR France SA
123 Rue Jules Guesde
92200 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection/infusion


Intravenous use




Poland


Fresenius Medical Care Nephrologica Deutschland GmbH
61346 Bad Homburg
Germany


Iron sucrose complex


Ferrologic 20 mg/ml


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Poland


Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria


Iron(III) isomaltoside complex


Ferrum-Lek


50 mg/ml


Solution for injection


Intramuscular use




Poland


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monover


100 mg/ml


Solution for injection/infusion


Intravenous use




Portugal


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Referen


100 mg/5 ml


Solution for injection


Intravenous use




Portugal


Vifor France, SA
7-13 Boulevard Paul Emile Victor
92200 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


100 mg/5 ml


Solution for injection


Intravenous use




Portugal


Combino Pharm Portugal, Unipessoal, Lda.
Lagoas Park
Edifício 8
Piso 0 2740-268 Porto Salvo
Portugal


Iron sucrose complex


Óxido Férrico Sacarosado Combino


100 mg/5 ml


Solution for injection


Intravenous use




Portugal


Farmoz — Sociedade Técnico Medicinal, S.A.
Rua da Tapada Grande, 2,
Abrunheira
2710-089 Sintra
Portugal


Iron sucrose complex


Óxido Férrico Sacarosado Farmoz


100 mg/5 ml


Solution for injection


Intravenous use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal


Iron sucrose complex


Óxido Férrico Sacarosado Generis


100 mg/5 ml


Solution for injection


Intravenous use




Portugal


Laboratórios Normon, S.A.
Rua Armando Villar,
Lote 42 1o Dto. Quinta das Patinhas, Cobre
2750 — 777 Cascais
Portugal


Iron sucrose complex


Óxido Férrico Sacarosado Normon


100 mg/5 ml


Solution for injection


Intravenous use




Portugal


Vifor France, SA
7-13 Boulevard Paul Emile Victor
92200 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Portugal


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Portugal


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Monofar


100 mg/ml


Solution for injection/infusion


Intravenous use




Romania


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


VENOFER®



20 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Romania


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


MONOFER 100 mg/ml


100 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Romania


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


FERINJECT 50 mg fer/ml


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




Slovak Republic


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use




Slovak Republic


Orion Corporation,
Orionintie 1,
FI-02200 Espoo,
Finland


Iron sucrose complex


Ferion 20 mg/ml


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Slovak Republic


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic 20 mg/ml


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Slovak Republic


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection


Intravenous use




Slovenia


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Slovenia


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


carboxymaltose


Iroprem 50 mg/ml raztopina za iniciranje ali infundiranje


50 mg/ml


Solution for injection/infusion


Intravenous use




Slovenia


Lek farmacevtska družba d.d.,
Verovškova 57,
1000 Ljubljana
Slovenia


Iron sucrose complex


Venofer 20 mg/ml raztopina za injiciranje/koncentrat za raztopino za infundiranje


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


COSMOFER 50 mg/ml SOLUCION PARA PERFUSION E INYECCION


50 mg/ml


Solution for injection
Solution for infusion


Intravenous use
intramuscular use




Spain


GUERBET B.P.
57400 ROISSY CdG
Cedex F-95943
France


Iron sucrose complex


ENDOREM 11,2  mg FE/ml CONCENTRADO PARA SUSPENSION PARA PERFUSION


11,2  mg/ml


Concentrate for suspension for infusion


Intravenous use




Spain


G.E.S. Genericos Espanoles Laboratorio
S.A.Cólquide, 6 — Portal 2, 1 Oficina F.Las Rozas
28230 MADRID
Spain


Iron sucrose complex


FERIV 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61346 Bad Homburg
Germany


Iron sucrose complex


HIERRO SACAROSA FME 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain


Laboratorios Normon S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos
Madrid
Spain


Iron sucrose complex


HIERRO SACAROSA NORMON 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain


Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37
DE-58638 Iserlohn
Germany


Iron sucrose complex


FERMED 100 mg/5 ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION


100 mg/5 ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


VENOFER 20 mg/ml SOLUCION INYECTABLE O CONCENTRADO PARA SOLUCION PARA PERFUSION


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




Spain


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


FERINJECT 50 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION


50 mg/ml


Solution for injection
Solution for infusion


Intravenous use




Spain


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


MONOFERRO 100 mg/ml SOLUCIÓN INYECTABLE O PARA PERFUSIÓN


100 mg/ml


Solution for injection
Solution for infusion


Intravenous use




Sweden


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92200 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer®



20 mg/ml


Concentrate for solution for injection


Intravenous use




Sweden


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Cosmofer®



50 mg/ml


Solution for injection


Intravenous use




Sweden


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92200 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection


Intravenous use




Sweden


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61346 Bad Homburg
Germany


Iron sucrose complex


Ferrologic


20 mg/ml


Concentrate for solution for injection


Intravenous use




Sweden


Orion Corporation,
Orionintie 1,
FI-02200 Espoo,
Finland


Iron sucrose complex


Ferion


20 mg/ml


Concentrate for solution for injection


Intravenous use




Sweden


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


MonoFer®



100 mg/ml


Solution for injection


Intravenous use




The Netherlands


Pharmamatch B.V.
Egelenburg 2
Amsterdam GK — 1081
The Netherlands


Iron sucrose complex


IJzerhydroxide sacharose complex bevattende 20 mg/ml IJzer PHARMAMATCH, oplossing/concentraat voor oplossing voor injectie


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




The Netherlands


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


FerroLogic 20 mg/ml, oplossing voor injectie of concentraat voor oplossing voor infusie


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




The Netherlands


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


MonoFer 100 mg/ml oplossing voor injectie/infusie


100 mg/ml


Solution for injection/infusion


Intravenous use




The Netherlands


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer 20 mg/ml ijzer (III), oplossing voor injectie of concentraat voor oplossing voor intraveneuze infusie


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




The Netherlands


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


FERINJECT 50 mg ijzer/ml, oplossing voor injectie/infusie


50 mg/ml


Solution for injection/infusion


Intravenous use




The Netherlands


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


CosmoFer 50 mg/ml oplossing voor infusie en injectie


50 mg/ml


Solution for injection/infusion


Intravenous use




The Netherlands


Pharmachemie B.V.
Haarlem — 2031 GA
The Netherlands


Iron sucrose complex


IJzerhydroxide sacharose complex 20 mg/ml PCH, oplossing voor injectie/concentraat voor oplossing voor infusie


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




United Kingdom


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Iron sucrose complex


Venofer


20 mg/ml


Solution for injection/infusion


Intravenous use




United Kingdom


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Monofer


100 mg/ml


Solution for injection/infusion


Intravenous use




United Kingdom


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron(III) isomaltoside complex


Diafer


50 mg/ml


Solution for injection


Intravenous use




United Kingdom


Pharmacosmos A/S
Roervangsvej 30
Holbaek DK-4300
Denmark


Iron (III) hydroxide dextran complex


Cosmofer


50 mg/ml


Solution for injection/infusion


Intravenous use
intramuscular use




United Kingdom


Fresenius Medical Care Nephrologica Deutschland GmbH
Else-Kröner-Strasse 1
61352 Bad Homburg
Germany


Iron sucrose complex


Ferrologic


20 mg/ml


Solution for injection
Concentrate for solution for infusion


Intravenous use




United Kingdom


VIFOR France SA
7-13 Boulevard Paul Emile Victor
92521 Neuilly-sur-Seine
France


Ferric carboxymaltose


Ferinject


50 mg/ml


Solution for injection/infusion


Intravenous use